A Phase II Study of BIND-014 in Patients with Metastatic Castration-Resistant Prostate Cancer

Protocol
13-090
Full Title
An Open Label, Multicenter, Phase 2 Study to Determine the Safety and Efficacy of BIND-014 (Docetaxel Nanoparticles for Injectable Suspension), Administered to Patients With Metastatic Castrate-Resistant Prostate Cancer
Phase
II
Purpose

Prostate cancers initially need the male hormone testosterone for growth. Hormone therapies that lower the level of testosterone are among the most effective treatments for prostate cancers that have spread to other organs (metastasized). The benefits of hormone treatments do not last, however. Over time, many prostate cancers continue to grow despite hormonal therapies (and are called “castration-resistant” prostate cancer).

Docetaxel is the chemotherapy drug most often give to men who develop castration-resistant prostate cancer, but often the cancer continues growing despite this drug. BIND-014 is an investigational drug made of tiny particles of docetaxel that may increase the amount of docetaxel that gets into tumor cells.

The purpose of this study is to evaluate the safety and effectiveness of BIND-014 in men with castration-resistant prostate cancer. BIND-014 is given intravenously (by vein).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have castration-resistant prostate cancer that may have been treated with hormonal therapy or radiation therapy but not chemotherapy.
  • Patients should have recovered from the side effects of prior treatments.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is open to patients ages 18 and older.

For more information and to inquire about eligibility for this study, please contact Dr. Howard Scher at 646-422-4330.

Disease(s)
Prostate Cancer: Metastatic Disease after Hormone-Reducing Therapy
Locations
Related Diseases